epoetin alfa (Epogen/Procrit)
epoetin alfa is an FDA-licensed reference biologic from Amgen Inc., with 1 approved follow-on biologic. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
1
Biosimilars
0
Interchangeables
0
Listed patents
—
Reference approved
Reference product
Epogen/Procrit epoetin alfa
Amgen Inc.
- Approved
- Not listed
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for epoetin alfa from the RCSB Protein Data Bank (PDB 1BUY).
Interactive biological assembly from PDB entry 1BUY. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for epoetin alfa, in chronological order.
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
29 yr ago
Biosimilars & interchangeables for epoetin alfa
1 FDA-licensed follow-on biologic referencing epoetin alfa.
| Product | Proper name | Applicant | Type | BLA | Approved |
|---|---|---|---|---|---|
| Retacrit | epoetin alfa-epbx | Hospira Inc., a Pfizer Company | Biosimilar 351(k) | 125545 | May 15, 2018 |
Frequently asked questions
What biosimilars are approved for epoetin alfa (Epogen/Procrit)?
The FDA Purple Book lists 1 approved follow-on biologic referencing epoetin alfa: Retacrit. Of these, 0 are interchangeable biosimilars and 1 is a 351(k) biosimilar.
Who makes epoetin alfa biosimilars?
Companies with FDA-approved follow-on biologics referencing epoetin alfa include Hospira Inc., a Pfizer Company.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.